Medical Affairs Support
Helvepharm AG
Publication date:
08 October 2024Workload:
100%- Place of work:Praha / Dolni Mecholupy
JOB PURPOSE:
- Provide medical assessment of selected molecules/therapeutic areas
- Provide review and follow up of certain medical materials
- Validation of medical sections in Periodic Benefit Risk Evaluation Reports (PBRERs)
- Medical information enquiries – support for second line responses
- Additional risk minimization measures - consultations with PV, validation of educational materials (e.g. Dear Healthcare Professional Communication)
- PV/MED evaluation of new projects – process coordination, medical evaluation of new candidates
- Participation in Portfolio Safety and Labelling Committee, ad hoc PSLC
Interfaces/Coordination (Internal/External)
Coordinates and cooperate locally with Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other departments as appropriate.
KEY ACCOUNTABILITIES / RESPONSIBILITIES:
- Provide support to medical team to support mainly PV and regulatory part of medical activities.
- Partner with PV and Regulatory team by acting as a coordinator for medical requirements.
- Perform medical evaluation/assessment of new molecules /therapeutic areas
- Miscellaneous filing, archiving and document gathering, as required.
JOB-HOLDER REQUIREMENTS:
Qualifications:
- Degree from accredited college or university in Medical or Pharmaceutical science
- Excellent skills in MS Office including Word, Power Point, Excel and Outlook.
Experience & knowledge :
- Business sense.
Languages :
- English – full professional proficiency
Core competencies:
- Strive for results
- Cooperate transversally
- Commit to customers
Additional Skills:
- Teamwork ability: interpersonal/communication skills
- Ability to work in a matrix organization
- Business and customer orientation
- Networking and influencing skills